生物相似藥上市申請面臨之專利問題

隨著科技進步，藥物發展迅速，出現多種新型態藥物，生物製藥是其中一種重要的藥物型態，此類藥物是以細胞或細菌為生產工廠產生之藥物，具有高專一性及低副作用的優點。近年來各大生物製藥廠的專利陸續到期，其他藥廠可以開始生產這些專利到期的生物製藥，但在生物製藥領域中，由於製程相異，可能影響到蛋白質立體結構或後修飾，造成分子結構有差異但療效相同之情形，故由其他藥廠生產的生物製藥稱為「生物相似藥」只能視為相似產品，這也是「生物相似藥」之名稱由來。由於生物製藥入門門檻高、研發困難、須耗費大量金錢及時間成本，且失敗率高，除世界知名大廠外，多數藥廠選擇從門檻較低之生物相似藥研發方向著手。隨著多項生物製藥專利將屆期，生物相似藥上市申請案增多，原生物製藥廠與生物相似藥廠間之專利侵權案例也逐漸累積。本論文先由生物製藥的特性、生產製程等技術資訊進行了解，接著分析比較生物相似藥在美國經由專利舞蹈制度與我國經由專利連結制度的上市程序，之後藉由美國生物相似藥上市時相關侵權案例，再進一步分析我國生物相似藥上市可能面臨之專利侵權問題，最後嘗試針對我國生物相似藥上市申請制度及生物製藥相關規範提出分析與建議。

關鍵字

生物製藥；生物相似藥；專利舞蹈；專利連結

並列摘要

With the advancement of technology and the rapid development of drugs, a variety of new types of drugs have emerged, and biologics are one of the important types of drugs. In recent years, the patents of major biopharmaceutical factories have expired one after another, and other pharmaceutical factories can start producing biopharmaceuticals whose patents have expired. However, in the field of biologics, different manufacturing processes may affect the three-dimensional structure or post-modification of proteins, resulting in different molecular structures but the same therapeutic effect. Therefore, biologics produced by other pharmaceutical companies are called "biosimilar drugs" which only can be regarded as similar products. Due to the high barriers to entry of biopharmaceuticals, the difficulty of research and development, the cost of a lot of money and time, and the high failure rate, except for world-renowned manufacturers, most pharmaceutical companies choose to start from the research and development direction of biosimilar drugs with lower thresholds. With the expiry of a number of biopharmaceutical patents, the number of biosimilar drug listing applications has increased, and the patent infringement cases between the original biopharmaceutical factory and the biosimilar drug factory have also gradually accumulated. This paper firstly understands the characteristics of biopharmaceuticals, production process and other technical information, and then analyzes and compares the listing procedures of biosimilar drugs in the United States through the patent dance system and Taiwan through the patent linkage system. Then, based on the related infringement cases of biosimilar drugs in the United States, we will further analyze the patent infringement problems that may be faced by biosimilar drugs in Taiwan. Finally, it tries to put forward analysis and suggestions on the application system of biosimilar drugs in Taiwan and related norms of biopharmaceuticals.